Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fudan University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age greater than 18 years old, both males and females are eligible.
2. Histologically confirmed diagnosis of non-small cell lung cancer.
3. Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.
4. EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.
5. Able to undergo R0 surgical resection.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. Expected survival of more than 12 months.
7. Baseline blood routine and biochemical indicators meeting the following criteria:
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times ULN.
8. Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.
You may not be if
1. Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).
2. Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
3. Rx, R1, R2 surgical resection.
4. Received blood transfusion during surgery or within 2 weeks before surgery.
5. Pregnant or lactating female patients.
6. History of other malignant tumors within the past 5 years, except for cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years, curable basal cell carcinoma of the skin, and cervical carcinoma in situ.
7. Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases).
8. Evidence of any other diseases, neurological or metabolic functional disorders, physical examination findings, or laboratory findings that would place the subject at high risk of treatment-related complications.
9. Other factors deemed by the investigators to potentially affect the study process.
Clareo Health | Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)
